This is a randomized non-blinded clinical trial to assess the effect of adding garlic extract to the standard three-drug treatment of helicobacter pylori. The study population consists of dyspeptic patients refered to gastroenterology clinic of Boali Hospital whose Rapid Urease Test are positive in endoscopy. Patients with acute gastrointestinal bleeding or who have been recently treated with antibiotics or proton pump inhibitors are excluded from the study. Sampling will begin from 2012-6-21 and sampling method is serial. Patients are randomly allocated to treatment and control groups.The base of treatment is Clarithromycine+ Amoxicillin+ Pantoprazol and in the treatment group garlic is added to this regime. 37 patients are recruited in each group. The efficacy of treatment is assessed by Urea Breathing Test 6 weeks following end of treatment. Data will be gathered by checklists filled by the physicians and anlyzed and presented in bars, charts and tables. The most important ethical issue is providing the basic required treatment for patients which is achieved by the standard treatment done in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109187493N2
Registration date:2012-06-02, 1391/03/13
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-06-02, 1391/03/13
Registrant information
Name
Reza Gholami
Name of organization / entity
Ghazvin University of Medical Sciences, Boali Hospital
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 2930
Email address
rgholami@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences, Deputy of Research
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of adding garlic extract to standard treatment regime of helicobacter pylori
Public title
The effect of garlic on helicobacter pylori treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Signs of dyspepsia or peptic ulcer; Positive rapid urease test
Exclusion criteria: Antiboitic therapy during the last month; Acute GI bleeding; Proton pump inhibitor treatment during the last month
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical University
Street address
Daneshgah Boulvard, Qazvin
City
Qazvin
Postal code
Approval date
2011-05-17, 1390/02/27
Ethics committee reference number
28/20/4413
Health conditions studied
1
Description of health condition studied
Helicobacter Pylori
ICD-10 code
B98.0
ICD-10 code description
Helicobacter pylori [H.pylori] as the cause of diseases classified